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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
510(k) Number K850694
Device Name WSP CODE 4310 STRESSCATH
Applicant
Warne Surgical Products, Ltd.
Portadown Rd., Lurgan,
Craigavon, Co.
Armagh Bt66 8rd,  IE
Applicant Contact LEWIS HAMILTON
Correspondent
Warne Surgical Products, Ltd.
Portadown Rd., Lurgan,
Craigavon, Co.
Armagh Bt66 8rd,  IE
Correspondent Contact LEWIS HAMILTON
Regulation Number876.1620
Classification Product Code
FAP  
Date Received02/21/1985
Decision Date 05/17/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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